MANSFIELD – Mallinckrodt, the pharmaceuticals business of biotechnology giant Covidien PLC, has received approval from the U.S. Food and Drug Administration to manufacture and market a generic version of its Concerta tablets for the treatment of attention deficit hyperactivity disorder, the company announced Monday.
Mallinckrodt holds six-month exclusivity on 27-, 36- and 54-milligram dosage strengths of the Methylphenidate HCl ER tablets for ADHD treatment.
The 180-day exclusivity begins on the commercial launch of each respective dosage strength. The company’s current plan is to have the 36mg and 54mg dosage strengths commercial available during the first three months of 2013.
Mallinckrodt plans to submit a supplement to its approved abbreviated new drug application for the 18mg dosage during the first calendar quarter of the new year.
“This approval represents an important addition to our line of generic pharmaceutical products, and we look forward to providing an affordable treatment option to patients coping with ADHD,” Mark Trudeau, Mallinckrodt president, said in prepared remarks. “We are pleased the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market.”
Mallinckrodt is the largest supplier of opioid pain medications in the United States and is among the top 10 generic pharmaceuticals manufacturers in the United States based on prescriptions.
In December 2011 Covidien announced that it plans to spin off Mallinckrodt into a stand-alone company, a process expected to be completed in mid-2013.